Structured Product Labeling (SPL) Terminology Files

The NCIt-SPL terminology files provided here support the cooperative efforts of the Food and Drug Administration (FDA) and the National Cancer Institute's Thesaurus (NCIt) to develop terminology that facilitates the processing and review of Structured Product Labeling Terminology Files data. The efforts are described more fully on the Structured Products Labeling web page.

SPL terminology files are available for download from this NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/SPL/) in two formats:

FDA-SPL_NCIt_Subsets.xls (Microsoft Excel 2003)*
FDA-SPL_NCIt_Subsets.txt (Tab-delimited text)

Each file has column headers on the first row:

Spreadsheet Column Content Description

Source The initials of the requesting agency, in this case, the FDA.

Subset Code The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.

Subset Name The name of the subset.

Concept Code The NCIt concept code attached to the PT concept.

Source PT The preferred term chosen by the FDA attached to the concept.

Source Definition A text definition of the term created by an FDA subject matter expert.

Source Synonym(s) Terms chosen by the FDA that are synonomous to the Preferred Term.

SPL terminology is bundled into subsets, identified by code and name in the second and third columns of each row. These are the names and definitions of the subsets.

Subset Name Subset Description

Structured Product Labeling Terminology All SPL terms belong to this subset.

Structured Product Labeling Color Terminology Terminology used for representation of the information on pharmaceutical product color in the framework of the Structured Product Labeling documents.

Structured Product Labeling Shape Terminology Terminology used for representation of the information on pharmaceutical product shape in the framework of the Structured Product Labeling documents.

Structured Product Labeling Drug Route of Administration Terminology Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents.

Structured Product Labeling Pharmaceutical Dosage Form Terminology Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the Structured Product Labeling documents.

Structured Product Labeling Package Type Terminology Terminology used for representation of the information on pharmaceutical product package type in the framework of the Structured Product Labeling documents.

Structured Product Labeling DEA Schedule Terminology Terminology used for representation of the information on the US Drug Enforcement Administration schedules of controlled substances in the framework of the Structured Product Labeling documents.

Structured Product Labeling Limitation Of Use Terminology Terminology used for representation of information on factors that could limit use of medical product for a specific indication in the framework of the Structured Product Labeling documentation.

Structured Product Labeling Type of Drug Interaction Consequence Terminology Terminology used to specify type of drug interaction consequence in the framework of the Structured Product Labeling documents.

Structured Product Labeling Pharmacokinetic Effect Consequences Terminology Terminology used for representation of information on consequences resulted from pharmacokinetic interactions between the drug and another drug or food in the framework of the Structured Product Labeling documentation.

Structured Product Labeling Flavor Terminology Terminology used for the representation of the information on a pharmaceutical product the most predominant flavor in the framework of the Structured Product Labeling documents.

Structured Product Labeling Marketing Category Terminology Terminology used for representation of the information on pharmaceutical product marketing category in the framework of the Structured Product Labeling documents.

Structured Product Labeling Business Operation Terminology Terminology used for representation of the information on business operations concerned with medical product development, manufacturing, and marketing in the framework of the Structured Product Labeling documents.

Structured Product Labeling Document Type Terminology Terminology that represents kinds of documents in supporting regulatory submissions in electronic format drug establishment registration and drug listing.

Structured Product Labeling Unit of Presentation Terminology Terminology that encompasses dosage form, package type, and unit of measurement (aka potency) terms used in supporting regulatory submissions in electronic format - drug establishment registration and drug listing.

Structured Product Labeling Substance Indexing Terminology Terminology used for representation of the information with substance indexing in the framework of the Structured Product Labeling documents.

Also included on the NCI EVS ftp site (http://evs.nci.nih.gov/ftp1/FDA/SPL/) are the following additional files:

About (This file)
Changes.txt (A text file of changes between the most recent and the current version of SPL terminology. For each change record, the Changes.txt contains a complete row of tab delimited data with the same data elements as described above. An "A" will precede any new concept additions, a "C" will precede any modification to existing concepts, and a "D" will precede any concepts that have been deleted.)
Version.txt (A text file that contains the version of NCI Thesaurus that corresponds to the current spreadsheet data. The database is reconciled the last Monday of every month. The files will be posted during the following two weeks. The version appears as YR.MOweek. An example is 11.02d which corresponds to the year 2011, the month of February, and the "d" refers to the fourth Monday of the month.)

N.B.: If there are no changes to the data for a particular month, the files will not be reposted. An update via the LISTSERV will be sent with this information. An NCI EVS SPL Data Terminology LISTSERV has been created for end users' questions and for update notifications. Please visit the following link to sign up for the LISTSERV and search for ncievs-spl-terms-L .

Archived files are available at:

Archive/ Directory of dated release versions.

Deprecated_FDA-SPL-NCIt_Subsets.xls contains SPL lists deprecated by the FDA.

Help requests on these files should go to NCIThesaurus@mail.nih.gov

* If an attempt to view the Excel spreadsheet results in a page of nonsense characters, check the security settings in Excel to permit viewing. This is achievable by clicking the highlighted bar above the data, but below the menu bar in the spreadsheet.

Spreadsheet Column	Content Description
Source	The initials of the requesting agency, in this case, the FDA.
Subset Code	The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.
Subset Name	The name of the subset.
Concept Code	The NCIt concept code attached to the PT concept.
Source PT	The preferred term chosen by the FDA attached to the concept.
Source Definition	A text definition of the term created by an FDA subject matter expert.
Source Synonym(s)	Terms chosen by the FDA that are synonomous to the Preferred Term.

Subset Name	Subset Description
Structured Product Labeling Terminology	All SPL terms belong to this subset.
Structured Product Labeling Color Terminology	Terminology used for representation of the information on pharmaceutical product color in the framework of the Structured Product Labeling documents.
Structured Product Labeling Shape Terminology	Terminology used for representation of the information on pharmaceutical product shape in the framework of the Structured Product Labeling documents.
Structured Product Labeling Drug Route of Administration Terminology	Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents.
Structured Product Labeling Pharmaceutical Dosage Form Terminology	Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the Structured Product Labeling documents.
Structured Product Labeling Package Type Terminology	Terminology used for representation of the information on pharmaceutical product package type in the framework of the Structured Product Labeling documents.
Structured Product Labeling DEA Schedule Terminology	Terminology used for representation of the information on the US Drug Enforcement Administration schedules of controlled substances in the framework of the Structured Product Labeling documents.
Structured Product Labeling Limitation Of Use Terminology	Terminology used for representation of information on factors that could limit use of medical product for a specific indication in the framework of the Structured Product Labeling documentation.
Structured Product Labeling Type of Drug Interaction Consequence Terminology	Terminology used to specify type of drug interaction consequence in the framework of the Structured Product Labeling documents.
Structured Product Labeling Pharmacokinetic Effect Consequences Terminology	Terminology used for representation of information on consequences resulted from pharmacokinetic interactions between the drug and another drug or food in the framework of the Structured Product Labeling documentation.
Structured Product Labeling Flavor Terminology	Terminology used for the representation of the information on a pharmaceutical product the most predominant flavor in the framework of the Structured Product Labeling documents.
Structured Product Labeling Marketing Category Terminology	Terminology used for representation of the information on pharmaceutical product marketing category in the framework of the Structured Product Labeling documents.
Structured Product Labeling Business Operation Terminology	Terminology used for representation of the information on business operations concerned with medical product development, manufacturing, and marketing in the framework of the Structured Product Labeling documents.
Structured Product Labeling Document Type Terminology	Terminology that represents kinds of documents in supporting regulatory submissions in electronic format drug establishment registration and drug listing.
Structured Product Labeling Unit of Presentation Terminology	Terminology that encompasses dosage form, package type, and unit of measurement (aka potency) terms used in supporting regulatory submissions in electronic format - drug establishment registration and drug listing.
Structured Product Labeling Substance Indexing Terminology	Terminology used for representation of the information with substance indexing in the framework of the Structured Product Labeling documents.